Surgical Outcomes of Vaginal Prolapse Repair With Elevate

Completed

• Conditions: Vaginal Prolapse

• Registration Number: NCT01190618
• Lead Sponsor: Larry Sirls

Brief Summary

The purpose of this study is to evaluate outcomes in patients having vaginal prolapse repair with the Elevate prolapse repair kit and compare these outcomes to patients who had a repair with Prolift. .

Detailed Description

The investigators hypothesize that the less invasive Elevate mesh results in a shorter operative time, lower blood loss, complications, postoperative pain and earlier discharge from the hospital.

Study Timeline

• Study Start: 2010-08
• Study First Submitted: 2010-08-26
• Study First Submitted QC: 2010-08-26
• Study First Posted: 2010-08-27
• Primary Completion: 2016-12-31
• Study Completion: 2016-12-31
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-14
• Last Update Posted: 2017-02-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 417

Inclusion Criteria

• Women who have had a vaginal repair with Elevate prolapse repair kit

Exclusion Criteria

• N/A

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Comparison of Outcomes	3 Months	To evaluate outcomes in patients having vaginal prolapse repair with the Elevate prolapse repair kit and compare these outcomes to patients who had a repair with Profift.

Trial Locations

Locations (1)

William Beaumont Hospital; 🇺🇸 Royal Oak, Michigan, United States